The Early Prediction of Sepsis in ICU | NCT05088850

Studies
The Early Prediction of Sepsis in ICU

NCT05088850

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Oct 22, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Prediction of Sepsis in Critical Patients

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 18, 2021

First Submission Date that Met QC Criteria

Oct 19, 2021

First Posted Date

Oct 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2021

Last Update Posted Date

Oct 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-sepsis			Other: no intervention
sepsis			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	non-sepsis sepsis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
confidence index of sepsis occurrence		sepsis occurrence in five hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who met all of the following criteria were included in the case group:

At least 14 years old.
Sepsis onset at least 5 hours after ICU admission.
Sepsis onset is the first instance since admission to the hospital.

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

At least 14 years old.
Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients that were admitted into the ICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ranran Li, PhD	Contact	18317059746		rebecca1009@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICU, Ruijin Hospital	Recruiting	Shanghai	Shanghai Municipality	200025	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36581881	Derived	Chen Q, Li R, Lin C, Lai C, Chen D, Qu H, Huang Y, Lu W, Tang Y, Li L. Transferability and interpretability of the sepsis prediction models in the intensive care unit. BMC Med Inform Decis Mak. 2022 Dec 29;22(1):343. doi: 10.1186/s12911-022-02090-3.